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510(k) Data Aggregation
(270 days)
The EarLens™ Contact Hearing Device transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.
The EarLens™ Contact Hearing Device (CHD) transmits amplified sound to compensate for hearing impairment by direct vibration of the tympanic membrane (eardrum). The EarLens™ CHD is composed of an external Audio Processor, which includes a Behind-the-Ear (BTE) Unit and an Ear Tip, a Tympanic Membrane Transducer (TMT), the EarLens™ Fitting Software (ELF), and a Charger with a Power Adapter. In this device, light is used to wirelessly transmit both signal and power from the Audio Processor to the TMT. The BTE sits behind the outer ear, housing the rechargeable battery, digital signal processor (DSP), microphones and drive electronics. The Ear Tip contains the light emitter and directs the light signal down the ear canal. The TMT resides at the end of the ear canal on the skin around the tympanic membrane. The TMT receives the light signal and converts it into direct vibration of the umbo of the tympanic membrane. The EarLens™ Charger charges two BTEs at the same time when connected to either the wall power adapter or from the internal battery contained in the Charger. The CHD is patientmatched for single patient use. The ELF enables the hearing professional to program the device specific to the patient's hearing needs. The EarLens™ Impression System is provided to the physician to enable the collection of a deep ear canal impression to create patient-matched TMTs for each patient.
The EarLens™ Contact Hearing Device (CHD) has undergone extensive testing to ensure its safety and effectiveness. Both non-clinical (bench) studies and clinical studies were conducted to support its performance and establish acceptance criteria.
The acceptance criteria and reported device performance are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity, skin sensitization, or irritation per ISO 10993 standards. Levels of Nickel leaching within safe European standards (EN1811). | All tests passed. No nickel leaching was noted, and traces of oxidation (discoloration) after prolonged wear were contained beneath the parylene coating, posing no safety risk. |
| Shelf Life/Sterility | Expected service life of 1 year. Device supplied non-sterile. | Expected service life of 1 year demonstrated through mechanical and reliability testing. Device provided non-sterile. |
| Electromagnetic Compatibility (EMC) | Max signal variation less than 3dB during EMC tests. Immunity to specified levels for home environment (ESD: +/- 8kV contact, +/- 15kV air; Power frequency magnetic fields: 30 A/m; Conducted RF: 3V r.m.s outside ISM, 6V r.m.s in ISM bands; Radiated immunity: 10 V/m 80 MHz - 2.6 GHz). Performance maintained within +/-3dB in close proximity to intentional radiators. | All EMC tests passed with no variation of more than 3dB observed, demonstrating adequate performance. All immunity tests passed at higher test levels, supporting use in the home environment and on aircraft (RTCA DO-160 Section 20 Category T). No degradation of performance in close proximity to intentional radiators. |
| Software Level of Concern | Minor, with failures unlikely to cause injury. Maximum Equivalent Pressure Output (MEPO) appropriately limited. | Level of Concern identified as Minor, deemed reasonable given MEPO limitations and hardware component selection. |
| Electrical Testing | Output Limiter Test: Battery current limited to 12mA ± 1mA at 4.2V. | Passed. |
| Harmonic Distortion Test: Distortion less than 5%. | Passed. | |
| Maximum Output Test (MEPO): Average MEPO ≤ 132 dB SPL. | Average MEPO on four temporal bone samples was 127dB SPL. Passed. | |
| Mechanical & Reliability Testing | Ear Tip Pull Test: Withstands 8oz pull force for 1095 cycles. | Passed. |
| Ear Tip Bend Test: Withstands 150° bend for 1095 cycles. | Passed. | |
| Ear Tip Twist Test: Withstands 150° twist for 1095 cycles. | Passed. | |
| Accelerated Aging Test (TMT): No performance degradation in TMT output and adhesive bond strengths after 1 year simulated aging at 65°C. | Passed. | |
| Accelerated Aging Test (Ear Tip): Less than 10% degradation in laser output. No degradation in adhesive bond strength when Ear Tip cable subjected to 10N force for 26 cycles after 1 year simulated aging at 75°C. | Passed. | |
| Maximum Force on Umbo: Maximum force exerted on the Umbo is ≤ 6mN. | Passed. | |
| Grasping Tab Mechanical Strength: Withstands pull forces of at least 1N. | Passed. | |
| Umbo Platform Mechanical Strength: Withstands forces of at least 0.25N. | Passed. | |
| MRI Safety | Device must be labeled "MR Unsafe" and patient provided with a card for TMT removal prior to MRI. | Device is labeled "MR Unsafe" and patient card is required. |
| Clinical Safety (Primary Endpoint) | No decrease in hearing sensitivity of more than 10 dB in PTA4 (500, 1000, 2000, 4000 Hz) after 4 months of device usage. | No decrease in hearing sensitivity of more than 10 dB was observed. No subject exhibited a >10 dB decrease at any frequency. |
| Clinical Safety (Secondary Endpoint - AEs) | All AEs temporary and resolved without sequelae. No serious device/procedure-related AEs. No overheating of the ear canal. | 31 AEs reported in 20 subjects/22 ears. All but one (sensation of fullness, unresolved but effectiveness not impacted) were temporary and resolved. No serious AEs. Ear canal temperature rise |
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